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Clinical Trials/NCT02698709
NCT02698709CompletedNot Applicable

Astigmatic Vector Analysis of Posterior Corneal Surface - a Comparison Among Healthy, Forme Fruste and Overt Keratoconus Corneas

University of Sao Paulo1 site in 1 country698 target enrollmentStarted: May 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
698
Locations
1
Primary Endpoint
Astigmatism corneal vectors (based on keratometric readings at the three millimeter optical zones for both corneal surfaces).

Study Overview

Brief Summary

The main purpose of this study is to determine new diagnostic criteria for an eye disease called keratoconus.

Detailed Description

Eyes of patients who distinctly present signs of keratoconus, for both eyes, at corneal tomography (an exam commonly used in such cases), and those who present such signs in only one eye were compared to eyes of unaffected patients. Several characteristics of anterior and posterior corneal astigmatism (special emphasis was given to the latter) were collectively assessed among all patients by a method referred to as vectorial analysis. Statistical tests were then performed, in an attempt to highlight differences among those three groups of patients and, eventually, define new diagnostic criteria.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Good-quality Scheimpflug scans (approved by the device in the ''Examination Quality Specification'').

Exclusion Criteria

  • Previous eye surgery or trauma, and any sort of corneal scarring that might interfere with keratometric data acquisition.

Outcomes

Primary Outcomes

Astigmatism corneal vectors (based on keratometric readings at the three millimeter optical zones for both corneal surfaces).

Time Frame: Through study completion, an average of 6 months.

Corneal tomography at an Scheimpflug-based tomographer

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Giuliano de Oliveira Freitas, MD.

MD

University of Sao Paulo

Study Sites (1)

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